Clinical Efficacy of Acupuncture in the Treatment of Temporomandibular Disorders (TMD)

Not Applicable

• Conditions: Temporomandibular Disorders

• Registration Number: NCT04210921
• Lead Sponsor: Beijing Hospital of Traditional Chinese Medicine

Brief Summary

This is a single-blinded, randomized controlled trial to explore the effectiveness of acupuncture in the treatment of the pain due to TMD using the latest diagnostic criteria combined with subjective and objective indexes.

Detailed Description

This is a single-blinded, randomized controlled clinical trial. A total of 60 participants will be randomly assigned to two different groups. The treatment group will receive acupuncture with real penetration of the needle, while participants in the control group will be treated with the Park sham needle. All participants will be given for 4 weeks of treatment and 4 weeks of follow-up.The primary end-point is the reducing in intensity of pain due to TMD, which will be evaluated before treatment, 4 weeks after treatment and follow-up (4 weeks after treatment) by using 0-10 visual analogue score. Secondary end points include Graded Chronic Pain Scale Version 2.0(GCPS 2.0),Jaw Functional Limitations Scale - 20-item (JFLS-20),Depression, Anxiety and Stress Scales (DASS-21),Pittsburgh sleep quality index (PSQI),Pressure Pain Threshold (PPT),Surface electromyogram(sEMG).

Study Timeline

• Study Start: 2019-04-01
• Study First Submitted: 2019-11-08
• Status Verified: 2019-12
• Study First Submitted QC: 2019-12-24
• Last Update Submitted: 2019-12-24
• Study First Posted: 2019-12-26
• Last Update Posted: 2019-12-26
• Primary Completion: 2020-06-30
• Study Completion: 2020-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. Pain disorders in accordance with Diagnostic Criteria for Temporomandibular Disorders (DC/TMD)
2. Pain in the jaw, temple, in the ear, in front of ear or headache in the temple at any sides, and pain or headache modified (remission or aggravation) with movement at least 3 months.
3. Cooperated in completing the clinical trial successfully without language and mental disorders.

Exclusion Criteria

1. Conditions that result in regional pain in temporomandibular joint.
2. Autoimmune diseases that result in regional pain in the temporomandibular joint.
3. Mental illness or substance abuse.
4. Pregnant women.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Visual analogue scale(VAS)	Baseline,Week- 4(treatment period) and Week-8(follow-up period)	VAS is an international scale which reflects pain intensity and it has a 10-cm line ranging from 0 cm (no pain at all) to 10 cm (extremely painful). Pain intensity or pain relief in the tempormandibular joints will be measured by VAS. And then the investigators will compare the change of different time frames.The total score of this index is 10, and the better effect with the lower score.

Secondary Outcome Measures

Name	Time	Method
Surface electromyogram(sEMG)	Baseline and Week- 4(treatment period)	The electrodes will be placed parallel to the muscle fibers of the specify what muschemuscle.EMG signal acquisition will be performed in three tasks: mandibular resting position (MR), during maximal voluntary contraction (MVC), and during habitual chewing (HC).
Graded Chronic Pain Scale Version 2.0(GCPS 2.0)	Baseline,Week- 4(treatment period) and Week-8(follow-up period)	This scale includes the description of the degree of pain, a description of function, and a description of the time period of pain, which will provide effective data of the degree of pain within 1 month.The result of the index is divided into 5 grades. The less pain and influence with the lower the grade.
Pressure Pain Threshold (PPT)	Baseline and Week- 4(treatment period)	Participants will sit comfortably and relax their muscles during this measurement. A needle will be pressed at a constant speed perpendicular to the skin (0.5kg /cm2/second).The evaluator will be informed as soon as the participants feel pain and then record the results of measurement. The treatment is effective If the participants show elevated PPT after 4 weeks of treatment.
Pittsburgh sleep quality index (PSQI)	Baseline,Week- 4(treatment period) and Week-8(follow-up period)	The total score of this scale is 21. The better the sleep quality with the lower score.
Jaw Functional Limitations Scale - 20-item (JFLS-20)	Baseline,Week- 4(treatment period) and Week-8(follow-up period)	This scale includes the evaluation of mastication limitation, the evaluation of vertical mobility limitation, the evaluation of verbal and nonverbal communication limitation.There are 20 items in this index, with a total score of 200 points. The better the mandibular function with the lower the score.
Depression, Anxiety and Stress Scales (DASS-21)	Baseline,Week- 4(treatment period) and Week-8(follow-up period)	This scale consists of three parts, 21 items in total. The total score of each part is 21 points. Less emotional distress with the lower the score.

Trial Locations

Locations (1)

Beijing Hospital of Traditional Chinese Medicine affiliated to the Capital Medical University; 🇨🇳 Beijing, China